TFN-ADVANCE 04.037.266SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982097460), received between Apr 17, 2018 and Feb 1, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K131548, K160167); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING A POLYTRAUMA CASE, A TFNA WAS PERFORMED AND THE WIRE MISSED THE NAIL. THE NAIL WAS EXPLANTED AND THEN DISCARDED. A LARGER SIZE OF NAIL WAS USED AND THE NAIL TECHNIQUE WAS SUCCESSFUL. DURING A CALCANEUS FRACTURE, A MOD MINI PLATE WAS USED AND THE SCREW DID NOT LOCK IT. THE SCREW WAS ALSO INSERTED AND THE MEASUREMENT OF THE SCREW WAS VERY LONG, AND THE SCREWDRIVER STRIPPED THE SCREW, THE SURGEON POWERED IT IN AND STRIPPED THE SCREW HEAD BECAUSE IT DID NOT STOP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 12MM/130 DEG TI CANN TFNA 460MM/RIGHT-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622451 ↗
• InjuryApr 17, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF A TFN-ADVANCED¿ PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL, BLADE, AND SCREW ON (B)(6) 2018 DUE TO BROKEN NAIL AND NONUNION. THE NAIL, HELICAL BLADE AND SCREW WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. THE NAIL CRACKED WHERE THE HELICAL BLADE INSERTS. THE BROKEN NAIL AND INTACT HELICAL BLADE AND SCREW WERE REMOVED AND REPLACED WITH AN ANGLED BLADE PLATE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THE PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) UNKNOWN SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7436927 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548, K160167. One submission often covers many models, so check the product and lot details in each record.

• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima